(87 days)
The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto™ II flow cytometry systems:
- BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes .
- BD Multitest IMK Kit with or without BD Trucount Tubes .
- BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
- BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes
Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur™ flow cytometry systems:
- BD Multitest IMK Kit with or without BD Trucount Tubes .
- BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
- BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes
- BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
- BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .
For in vitro diagnostic use.
The BD FACS™ Sample Prep Assistant III (SPA III) is a microprocessorcontrolled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCalibur flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis.
The SPA III pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning procedures. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.
Here's a breakdown of the acceptance criteria and study information for the BD FACS™ Sample Prep Assistant III, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study/Criterion | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | Demonstrate equivalent performance for sample preparation. | The SPA III with the BD FACSCalibur system demonstrated equivalent performance in its ability to prepare human whole blood for flow cytometric analysis. |
| Precision | System precision within specification. | The SPA III demonstrated system precision within specification. |
| Carryover | System carryover within specification. | The SPA III demonstrated system carryover within specification. |
Important Note: The document does not explicitly state numerical acceptance criteria for accuracy, precision, or carryover. It refers to established guidelines (CLSI document EP9-A2 for Accuracy, CLSI document EP5-A2 for Precision, and Class II Special Controls Guidance Document for Carryover) which likely define these specifications. The reported performance is qualitative, stating that the device "demonstrated equivalent performance" or was "within specification."
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The "Accuracy" study mentions "Patient Samples," but the number of samples used is not provided.
- Data Provenance: Not explicitly stated. The document describes the device preparing "human whole blood," implying human samples were used, but the country of origin is not mentioned. The studies appear to be prospective, laboratory-based evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The studies listed (Accuracy, Precision, Carryover) are performance assessments of the automated system itself, not studies relying on interpretation by experts to establish a "ground truth" for diagnostic purposes. The ground truth for these types of studies would likely be objective measurements or comparisons against established manual methods or reference instruments.
4. Adjudication Method for the Test Set:
This information is not provided. As noted above, the studies are performance assessments, not expert-opinion-based diagnostic studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not conducted. This type of study typically involves human readers interpreting diagnostic images or data, and the BD FACS™ Sample Prep Assistant III is an automated sample preparation device, not an interpretive diagnostic tool.
6. Standalone (Algorithm Only) Performance:
Yes, a standalone performance assessment was done. The studies listed (Accuracy, Precision, Carryover) are evaluations of the device's performance in preparing samples. The "results" section directly refers to the "SPA III" or "SPA III with the BD FACSCalibur system" demonstrating equivalent performance or being within specification, indicating that the device's automated functions were assessed directly.
7. Type of Ground Truth Used:
The type of ground truth used would be based on objective measurements and comparisons against established reference methods.
- For Accuracy, the "Method Comparison and Bias Estimation" likely compared results from samples prepared by the SPA III to results from samples prepared by a predicate device or a manual, gold-standard method.
- For Precision, the ground truth would be statistical measures of reproducibility and repeatability based on replicate measurements.
- For Carryover, the ground truth would be the absence or minimal presence of analytes from a high-concentration sample in a subsequent low-concentration sample, measured objectively.
8. Sample Size for the Training Set:
This information is not applicable or not provided. The BD FACS™ Sample Prep Assistant III is an automated pipetting and diluting system. It is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its functionality is based on pre-programmed protocols and mechanical precision, not learned patterns from data.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as the device does not utilize a training set in the context of AI/machine learning. Its "ground truth" for operational accuracy and precision would be established through engineering specifications, calibration, and validation against known standards during its development and manufacturing.
§ 862.2750 Pipetting and diluting system for clinical use.
(a)
Identification. A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.